Pharmacovigilance and Adverse Drug Reaction Reporting

Pharmacovigilance encompasses the science and activities aimed at detecting, assessing, understanding and preventing adverse effects or any other drug-related problems. Central to this discipline is the systematic collection of suspected adverse drug reactions (ADRs) through spontaneous reporting systems, electronic health records and consumer reports. These reports feed into national and international databases, where signal detection algorithms and expert review identify new safety concerns and guide regulatory action. Despite ongoing efforts to harmonise reporting standards, under-reporting remains widespread, often due to lack of awareness, time constraints and fragmented training. Recent advances in machine learning and natural language processing have improved data quality and completeness, while digital platforms and mobile applications have expanded patient and healthcare-professional engagement. Globally, pharmacovigilance drives safer prescribing, informs benefit–risk assessments and underpins public health interventions, from vaccine safety monitoring to the scrutiny of herbal and traditional remedies. The interplay between policy, education and technology continues to shape emerging best practice, ensuring that pharmacovigilance remains integral to drug development and post-marketing surveillance.

Research from Nature Portfolio

A cross-sectional survey among community pharmacists in Saudi Arabia revealed that while over half demonstrated baseline knowledge of pharmacovigilance, only a small fraction recognised the national centre responsible for ADR collection. Key facilitators of reporting included financial incentives and streamlined submission processes, whereas lack of time and low institutional support were significant barriers. Positive attitudes towards ADR reporting were widespread, underscoring the potential impact of targeted education, simplified reporting tools and clearer professional roles in enhancing spontaneous report rates.

Pharmacovigilance and Adverse Drug Reaction Reporting publication trend

The graph below shows the total number of articles in pharmacovigilance and adverse drug reaction reporting across all publications each year (not limited to Nature Index journals).

Technical terms

Adverse Drug Reaction (ADR): Any unintended and harmful response to a medicine at normal doses for prophylaxis, diagnosis or therapy.

Pharmacovigilance: The science of detecting, evaluating and preventing adverse effects or other drug-related problems.

Spontaneous Reporting: Voluntary submission of suspected ADRs by healthcare professionals or consumers to regulatory authorities.

Signal Detection: The process of identifying new or rare safety issues from pharmacovigilance data using statistical algorithms and expert review.

vigiGrade Completeness Score: A metric assessing the quality and completeness of individual case safety reports, guiding improvements in reporting practices.

References

1. Data-Driven Identification of Factors That Influence the Quality of Adverse Event Reports: 15-Year Interpretable Machine Learning and Time-Series Analyses of VigiBase and QUEST. JMIR Medical Informatics (2024).
2. Exploring the knowledge, perception, and practice of community pharmacists in Saudi Arabia toward pharmacovigilance and adverse drug reaction reporting. A nationwide survey. Scientific Reports (2024).
3. Estimating Adverse Events Associated With Herbal Medicines Using Pharmacovigilance Databases: Systematic Review and Meta-Analysis. JMIR Public Health and Surveillance (2024).
4. Pharmacovigilance in low‐ and middle‐income countries: A review with particular focus on Africa. British Journal of Clinical Pharmacology (2022).